ASCO24: An early look at cancer drug study results
Bio Pharma Dive
MAY 23, 2024
Clinical trial abstracts posted by ASCO Thursday give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus Biosciences.
Thu.May 23, 2024
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AstraZeneca and Nona Biosciences sign agreement for monoclonal antibody
Pharmaceutical Technology
MAY 23, 2024
AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.
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Orna, a circular RNA specialist, acquires a buzzy startup
Bio Pharma Dive
MAY 23, 2024
After laying off staff late last year, Orna is expanding through the purchase of ReNAgade Therapeutics, which was built around technology designed to more effectively deliver RNA-based medicines.
Merck’s MilliporeSigma agrees to acquire Mirus Bio for $600m
Pharmaceutical Technology
MAY 23, 2024
Merck KGaA’s MilliporeSigma has entered a definitive agreement for the acquisition of Mirus Bio in a deal totaling $600m (€500m).
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Certain menopausal hormone therapy could raise ovarian cancer risk, study finds
Bio Pharma Dive
MAY 23, 2024
The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.
Ozempic Could Be Good For Your Heart Even If You Don’t Lose Weight
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
The medicine behind Ozempic and Wegovy, called semaglutide, could have significant benefits for heart health, reducing the risk of stroke or cardiac arrest even in those who don’t lose weight. The data comes from the largest and longest clinical trial on semaglutide use amongst those without diabetes, called the Semaglutide and Cardiovascular Outcomes (SELECT) trial.
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CDSCO reminds medical device firms to pay retention fee to continue holding licenses & certificates
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.
Merck KGaA to buy gene therapy tools maker for $600M
Bio Pharma Dive
MAY 23, 2024
The German drugmaker is bolstering its MilliporeSigma business with a unit of Gamma Biosciences that specializes in so-called transfection reagents.
Researchers combine herpes virus with cancer vaccine to treat brain cancer in children
Pharma Times
MAY 23, 2024
High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours
At long last, AstraZeneca, Pfizer, J&J, Roche and others have an ally in Biden
Fierce Pharma
MAY 23, 2024
Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma drug pricing, the industry has rarely seen good news coming from the White House. | Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma's pricing, the industry has rarely seen good news coming from the White House.
UK MRC and AstraZeneca partner for translational clinical research
Pharma Times
MAY 23, 2024
The partnership will provide six MRC clinical fellows with industry placement opportunities
Otsuka cuts development for AVP-786 following Phase III flop
Pharmaceutical Technology
MAY 23, 2024
After analysing data from a recent Phase III trial, Otsuka terminated its clinical program for AVP-786.
Navigating the Complex Regulatory CRO Landscape for Oncology Trials in the European Union
Worldwide Clinical Trials
MAY 23, 2024
By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS).
Boehringer outlines up to $33.6m for cancer asset from OSE Therapeutics
Pharmaceutical Technology
MAY 23, 2024
Boehringer and OSE have also expanded two solid tumour programmes into cardiovascular-renal-metabolic (CRM) indications.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
ASCO: Bristol Myers unveils I-O triplet data in melanoma as Iovance touts ‘paradigm-changing’ combo result
Fierce Pharma
MAY 23, 2024
Over the years, melanoma has become a popular testing ground for researchers to explore new immuno-oncology approaches. | With prior approvals in melanoma, Bristol Myers Squibb and Iovance are now showcasing early clinical data for their novel combinations in small first-line melanoma trials.
Magazine: Lula’s progress plan for Brazil: a year on
Pharmaceutical Technology
MAY 23, 2024
In this issue: Lula's progress plan for Brazil, tracking opioid lawsuit settlements in the US, the cell & gene therapy landscape in the US, the latest on ESG in pharma, and more.
Merck builds in cell, gene therapies with Mirus Bio deal
pharmaphorum
MAY 23, 2024
Merck KGaA has agreed to a $600m deal to buy Mirus Bio, a specialist in transfection reagents used in the production of cell and gene therapies.
Patients and caregivers driving innovation in drug development
Pharmaceutical Technology
MAY 23, 2024
Experts at OCT East Coast discuss the integral roles of patients and caregivers throughout a clinical trial’s lifecycle.
Clonal Hematopoiesis and Cancer Genetics: How Are They Linked, How Is Research Evolving?
XTalks
MAY 23, 2024
One of the more intriguing developments in cancer research in recent years is the growing understanding of clonal hematopoiesis, a phenomenon where blood cells expand from a single clone due to genetic mutations. Clonal hematopoiesis increases in prevalence with age and can precede hematologic malignancies. This area of study not only provides insights into the aging process but also has significant implications for cancer diagnostics, treatment strategies and new therapy development.
Overcoming the barriers to diverse and inclusive patient recruitment
Pharmaceutical Technology
MAY 23, 2024
Experts at the OCT East Coast 2024 conference discussed the challenges and solutions for diverse recruitment, particularly as it pertains to rare disease.
J&J faces allegations it used 'fraudulent maneuvers' to avoid compensating talc plaintiffs
Fierce Pharma
MAY 23, 2024
As Johnson & Johnson sorts through a mountain of litigation claiming its talcum-based powders caused users to develop cancers, the company has now been slapped with a related but different | Women represented by six law firms who previously filed lawsuits against J&J over talc claims have filed a proposed class action lawsuit in U.S. federal court in New Jersey.
Pfizer starts $1.5bn cost-cutting initiative amidst declining Covid-19 revenues
Pharmaceutical Technology
MAY 23, 2024
The cost saving programme is expected run over multiple years and will save the company about $1.5bn by 2027.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Second fire at Novo Nordisk in a week now under control
pharmaphorum
MAY 23, 2024
Novo Nordisk’s second facility fire in a week is under control, although the office in Bagsvaerd affected by the latest blaze isn’t expected to be salvageable.
EC approves Sandoz’s biosimilars for bone-related ailments
Pharmaceutical Technology
MAY 23, 2024
The EC has granted marketing authorisation for Sandoz’s biosimilars, Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments.
Chinese firm throws lifeline to Pfizer UK plant workers
pharmaphorum
MAY 23, 2024
China’s Asymchem Laboratories has agreed to take over the operation of a Pfizer manufacturing facility in Sandwich, UK, saving dozens of jobs.
Biogen enters deal to acquire HI-Bio for $1.8bn
Pharmaceutical Technology
MAY 23, 2024
Biogen has signed a definitive agreement to acquire Human Immunology Biosciences (HI-Bio) in a deal worth $1.8bn.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Cytokinetics eyes go-it-alone strategy for aficamten
pharmaphorum
MAY 23, 2024
Cytokinetics has been a top biotech takeover candidate for some time, thanks to blockbuster speculation about its lead drug aficamten, but a $1 billion-plus set of financing deals shows it is prepared to go to market on its own.
Asymchem Takes Ownership of Former Pfizer Manufacturing Facilities
Pharmaceutical Commerce
MAY 23, 2024
The CDMO will run the active pharmaceutical ingredient pilot plant in Sandwich, UK, along with development laboratories.
Which companies will last? Success begins with the basics
pharmaphorum
MAY 23, 2024
In the post-COVID world, which start-ups will thrive and which will fizzle? Discover the fundamental strategies that separate the winners from the losers.
Biogen Agrees to Acquire HI-BIO for $1.15 Billion
Pharmaceutical Commerce
MAY 23, 2024
The deal features felzartamab, an investigational anti-CD38 monoclonal antibody, whose clinical outcomes have shown potential to tackle various immune-mediated diseases.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
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